Fosamprenavir (Lexiva) approved in US

On 20 October the US Food and Drug Administration approved the protease inhibitor fosamprenavir (Lexiva, GW908). Fosamprenavir is a pro-drug of amprenavir (Agenerase). This new formulation requires fewer pills than amprenavir (now usually four pills a day including the ritonavir, vs. 16 pills a day for Agenerase), and no food restrictions.

European approval is expected to follow in about six months and until then fosamprenavir remains available on an expanded access programme.

Information for doctors and patients is at:

Other links:

Brief review by the FDA of the pivotal clinical trials:

GSK review:

An extensive review by the activist organisation TAG (Treatment Action Group), supporting approval – but only when Lexiva is “boosted” with a low dose of ritonavir to increase blood levels of Lexiva:

Combinations, adverse events, dosing, interactions, resistance:

Source: AIDS Treatment News

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